Design Quality Engineer I – CST – Boxborough, MA (Onsite)
Core
Ensuring product quality and regulatory compliance for spinal and cranial imaging systems throughout the product lifecycle.
Role type
Design Quality Engineer I
Builds
Spinal implants, navigation and robotic guidance systems, advanced imaging, and data-driven planning tools
Domain
Medical device / Healthcare technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, statistical analysis, inspection and testing method development, CAPA management, regulatory compliance documentation, engineering change order review
Preferred skills
engineering investigations, quality systems knowledge, data analysis
Technologies
AiBLE™, imaging systems, robotic guidance systems
Responsibilities
Review and approve quality engineering aspects of engineering change orders; Investigate field complaint trends and support root cause analysis; Assist in testing and evaluating proposed product design changes; Develop and implement inspection, testing, and evaluation methods; Support the design and qualification of inspection and testing equipment; Participate in or lead Corrective and Preventive Action (CAPA) activities
Seniority
Entry-level, hands-on IC